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Life sciences · Interventional Study
ClinicalTrials.gov · October 27, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07897006). This is a study registration, not published results. Lead sponsor: Shanghai Jiao Tong University School of Medicine. Recruitment status: NOT_YET_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 210 participants (ESTIMATED). Conditions: Sepsis, Disseminated Intravascular Coagulation (DIC). Interventions: OTHER: High-dose safflower granules; OTHER: Medium-dose safflower granules; OTHER: Placebo granules (one-tenth of medium-dose safflower). Primary outcome measures: Change in SOFA score from baseline to Day 14 , From baseline (before the first dose) through Day 14. Brief summary: Sepsis is a life-threatening condition in which infection triggers widespread inflammation and blood clotting abnormalities. Many patients with sepsis develop coagulopathy (impaired blood clotting), which contributes to organ damage and death. Safflower (Carthamus tinctorius L.) is a traditional Chinese medicine herb with documented anticoagulant, anti-platelet, and blood vessel-protective properties. This randomized, double-blind, placebo-controlled trial will enroll 210 adult patients with sepsis-associated coagulopathy at Ruijin Hospital. Participants will be randomly assigned to one of three groups: high-dose safflower granules (equivalent to 9 g of raw herb daily), medium-dose safflower granules (equivalent to 6 g of raw herb daily), matching placebo (equivalent to 0.6 g of raw herb daily for blinding). The granules are dissolved in 50 mL of warm water and given through a nasogastric tube once daily for 7 days, in addition to standard sepsis treatment. The primary outcome is the improvement in the SOFA score (a measure of organ function) at 14 days. Secondary outcomes include DIC scores, coagulation tests, endothelial injury and platelet markers, inflammatory markers, 28-day mortality, length of ICU and hospital stay, and adverse events. The study is funded by Ruijin Hospital as an investigator-initiated trial.